FLORBETABEN F-18 Recall D-1177-2023
Description: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
FLORBETABEN F-18 Recall D-1177-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1177-2023 |
| Event ID | 93073 |
| Brand | NEURACEQ |
| Generic Name | FLORBETABEN F 18 |
| Manufacturer | FLORBETABEN F 18 |
| Original Package? | 1 |
| Active Substance | FLORBETABEN F-18 |
| Drug Route | INTRAVENOUS |
| Distribution | Product was released to one facility in VA. |
| Quantity | 6 patient doses |
| Recall Reason | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). |
| Drug Classification | Class II |
| Drug Code Info | 20231004 |
| Product NDC | 54828-001 |
| Product NUI | N0000177914 N0000175869 |
| Pharma Class (EPC) | Radioactive Diagnostic Agent [EPC] |
| Recall Initiation Date | 20230822 |
| Report Date | 20231004 |
| Classification Date | 20230926 |
| Address | 100 Executive Dr Ste 6 Sterling, VA 20166-9507 United States |
| Recalling Firm | Sofie Co dba Sofie |
| Initial Notification | Telephone |
| Unique Ingredient Identifier | TLA7312TOI |
| Drug Application Number | NDA204677 |
| Structured Product Labeling (SPL ID) | eb884bdb-3ff8-4765-8ee8-550a583c4bac |
| Structured Product Labeling (SPL Set ID) | b0915068-cfd4-4d72-b9f8-7e31fe83cd1e |
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